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Welcome to OncologyPRO, the home of ESMO’s educational and scientific resources, with Guidelines, a comprehensive list of E-Learning modules, Factsheets on biomarkers, slides and webcasts from our educational programme, and more... to support continuing medical education and daily practice!

RFS, OS, DMFS, and FFR were all improved with adjuvant dabrafenib plus trametinib compared to placebo

Combined dabrafenib plus trametinib as an adjuvant treatment for patients with high-risk BRAF V600-mutated melanoma after surgical resection significantly decreased the risk of death or recurrent disease, according to findings from the phase III COMBI-AD study presented at ESMO 2017, the Annual Congress of the European Society for Medical Oncology in Madrid, Spain.

Axel Hauschild, University Hospital Schleswig-Holstein, Kiel, Germany and colleagues conducted this trial to develop an adjuvant regimen for patients with melanoma and regional nodal involvement (stage III disease), who are still at a high risk for relapse and death after a complete lymphadenectomy.

The primary endpoint of relapse-free survival was met

After a median follow up of 2.8 years, the risk of disease recurrence or death was reduced by adjuvant dabrafenib plus trametinib by 53% compared to placebo, hazard ratio [HR] 0.47; 95% confidence interval [CI] 0.39, 0.58.

Secondary endpoint also showed a benefit; the hazard ratio for OS was 0.57 in favour of the combination (95% CI, 0.42, 0.79), for DMFS the HR was 0.51 (95% CI 0.40, 0.65), and FFR was HR 0.47 (95% CI 0.39, 0.57).

Forty-one percent of patients had grade 3/4 adverse events (AEs) in the combination arm compared to 14% of patients on placebo. Additionally, 26% of patients in the dabrafenib plus trametinib arm discontinued the trial due to an AE compared to 3% of patients in the placebo arm. The type and severity of treatment-related AEs did not differ from already known toxicities observed in randomised trials for advanced unresectable metastatic melanoma leading to the approval for this stage of melanoma in 2015.

Conclusions

In COMBI-AD, adjuvant therapy with dabrafenib and trametinib was associated with improvements in RFS, OS, DMFS, and FFR, and demonstrated manageable safety in patients with high-risk, resected, stage III, BRAF V600E/K–mutated melanoma.

The authors concluded that a combined dabrafenib and trametinib regimen represents a new adjuvant treatment option in this setting.